Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4: Difference between revisions
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| | | [[Glossary:TAG-00020-Cli-nit|CRA / Monitor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00155-Med-Med|Medical device]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | MD |
| Document name | Regulation (EU) 2017/745 - Medical Device Regulation |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.3.1 |
| Scope | MD |
| Document part | Annex XV
Chapter III Section 4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | CRA / Monitor, Sponsor responsibilities, Investigation plan, Good clinical practice, Medical device |
| Comment | Sponsor obligation to appoint independent monitor |
Content
OTHER OBLIGATIONS OF THE SPONSOR
4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
